Lung AdenocarcinomaNCT06056115
Efficacy and Safety of Tislelizumab for Lung Adenocarcinoma With Asymptomatic Brain Metastatic
A study testing Tislelizumab,Platinum in people with Lung Adenocarcinoma, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
Brain metastasis of lung cancer is one of the most important metastasis pathways in patients with life-threatening diseases. This study explore the efficacy and safety of Tislelizumab combining with platinum-containing drug chemotherapy in the first-line treatment of Lung Adenocarcinoma With Asymptomatic Brain… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Adenocarcinoma
- What is being tested?
- Tislelizumab,Platinum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 12 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with metastatic (stage IV) lung adenocarcinoma who have not been systematically treated and are histologically or cytologically confirmed as unable to undergo radical surgery or radiotherapy based on AJCC Stage VIII;
- Patients with brain metastases confirmed by imaging;
- Patients with asymptomatic BMS after initial diagnosis, local BMS surgery or radiotherapy;
- ECOG PS: 0-1;
- Measurable target lesions outside the skull (as per RECIST 1.1);
- Life expectancy greater than 3 months;
Who cannot join
- Patients had been treated with immune checkpoint inhibitors such as anti-PD-1, PD-L1, or CTLA-4 therapy;
- The patient had received systemic chemotherapy as advanced treatment;
- Patients with EGFR mutation or ALK gene translocation;
- The patient had received approved systemic anticancer therapy or systemic immunomodulators (including but not limited to interferon, interleukin 2, and tumor necrosis factor) within 4 weeks prior to initial administration;
- Clinically uncontrolled pleural fluid or ascites requiring puncture drainage within 2 weeks prior to initial administration;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital)
Shijiazhuang, Hebei
Jian Shi, Dr., +86-311-86095794, Shijian6668@126.com
About this study
Official title: Efficacy and Safety of Tislelizumab Combined With Platinum-containing Drug Chemotherapy in First-line Treatment of Lung Adenocarcinoma With Asymptomatic Brain Metastatic
Brain metastasis of lung cancer is one of the most important metastasis pathways in patients with life-threatening diseases. This study explore the efficacy and safety of Tislelizumab combining with platinum-containing drug chemotherapy in the first-line treatment of Lung Adenocarcinoma With Asymptomatic Brain Metastatic. Meanwhile, Related biomarkers were explored to provide theoretical basis for efficacy evaluation and resistance mechanism.
- Conditions
- Lung Adenocarcinoma
- Being tested
- Tislelizumab,Platinum
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab,PlatinumDrug
- Induction therapy stage: Tislelizumab plus platinum-containing drug chemotherapy was administered every 3 weeks and was expected to complete 6 cycles of treatment.
- Maintenance treatment phase:
After completion of the induction therapy phase, patients whose antitumor response was confirmed as complete response, partial response, and disease stable according to RECIST v1.1 criteria were admitted to maintenance therapy .
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab Combined With Platinum-containing Drug Chemotherapy | Experimental | 1. Tislelizumab PD-1 inhibitor
2. Platinum-containing drug chemotherapy Receives: Drug: Tislelizumab,Platinum |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 years PFS
the time from the date of first dose of study treatment to the date of first documentation of disease progression using RECIST v1.1 or death, whichever occurs first
Measured: up to 1year
Secondary outcomes (1)
The objective response rate (ORR)
Assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Measured: Through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 May 2023
- Primary completion12 Apr 2025 (estimated)
- Study completion12 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian SHI, Hebei Medical University Fourth Hospital
- Investigators
- Jian Shi, Dr., Principal investigator, The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056115
- Sponsor's protocol ID
- 20220511
- Status last verified
- Sep 2023
- First submitted
- 11 Apr 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tislelizumab Combined With Platinum-containing Drug Chemotherapy in First-line Treatment of Lung Adenocarcinoma With Asymptomatic Brain Metastatic
- ClinicalTrials.gov ID
- NCT06056115
- Acronym / sponsor ID
- 20220511
- Conditions
- Lung Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 12 Apr 2025 (estimated)
- Study completion
- 12 Dec 2026 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brain metastasis of lung cancer is one of the most important metastasis pathways in patients with life-threatening diseases. This study explore the efficacy and safety of Tislelizumab combining with platinum-containing drug chemotherapy in the first-line treatment of Lung Adenocarcinoma With Asymptomatic Brain Metastatic. Meanwhile, Related biomarkers were explored to provide theoretical basis for efficacy evaluation and resistance mechanism.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab Combined With Platinum-containing Drug Chemotherapy | Experimental | Drug: Tislelizumab,Platinum1. Tislelizumab PD-1 inhibitor 2. Platinum-containing drug chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with metastatic (stage IV) lung adenocarcinoma who have not been systematically treated and are histologically or cytologically confirmed as unable to undergo radical surgery or radiotherapy based on AJCC Stage VIII;
- Patients with brain metastases confirmed by imaging;
- Patients with asymptomatic BMS after initial diagnosis, local BMS surgery or radiotherapy;
- ECOG PS: 0-1;
- Measurable target lesions outside the skull (as per RECIST 1.1);
Key exclusion criteria (5 listed)
- Patients had been treated with immune checkpoint inhibitors such as anti-PD-1, PD-L1, or CTLA-4 therapy;
- The patient had received systemic chemotherapy as advanced treatment;
- Patients with EGFR mutation or ALK gene translocation;
- The patient had received approved systemic anticancer therapy or systemic immunomodulators (including but not limited to interferon, interleukin 2, and tumor necrosis factor) within 4 weeks prior to initial administration;
- Clinically uncontrolled pleural fluid or ascites requiring puncture drainage within 2 weeks prior to initial administration;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tislelizumab,Platinum1. Induction therapy stage: Tislelizumab plus platinum-containing drug chemotherapy was administered every 3 weeks and was expected to complete 6 cycles of treatment. 2. Maintenance treatment phase: After completion of the induction therapy phase, patients whose antitumor response was confirmed as complete response, partial response, and disease stable according to RECIST v1.1 criteria were admitted to maintenance therapy . | Drug | Tislelizumab Combined With Platinum-containing Drug Chemotherapy |
Primary outcome
1 years PFS
Time frame: up to 1year
the time from the date of first dose of study treatment to the date of first documentation of disease progression using RECIST v1.1 or death, whichever occurs first
1 secondary outcome
The objective response rate (ORR)
Time frame: Through study completion, an average of 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jian Shi, Dr. principal investigator
The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tislelizumab,Platinum in people with Lung Adenocarcinoma, run by Hebei Medical University Fourth Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Shi, Dr. (+86-311-86095794, Shijian6668@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 years PFS (time frame: up to 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.